A skin in situ immune cell detection kit for the diagnosis and classification of cutaneous lupus erythematosus

BACKGROUND: Although lupus can be diagnosed by first impression, medical history, physical examination, pathological analysis and laboratory tests, the accurate classification of cutaneous lupus erythematosus (LE) is still a major challenge in the clinic, which might mislead the selection of treatments and miss the right time for the administration of therapies. The goal of this study was to establish a novel kit to assist with the diagnosis and classification of cutaneous lupus. METHODS: Sixty-five patients from three hospitals were included in this study, including 50 patients with LE and other similar skin diseases. We invited two dermatology specialists to make an accurate diagnosis of the subtypes of lupus based on the patient’s clinical features, laboratory examination tests, pathology manifestation analysis, medical treatments and follow-up records. Then, we used their diagnosis results as a standard to which we successively compared the consistency of each step of our diagnosis processes, including impression diagnosis, pathology diagnosis, the combined consideration of the former two diagnostic analyses, and the results of an in situ immune cell detection kit to assist in arriving at a judgement. RESULTS: By Cohen’s kappa analysis, we found that the results of the in situ immune cell detection kit had the highest consistency with the diagnoses of the two specialists, both for the diagnosis (k=0.921) and for the classification of cutaneous lupus (k=0.940). In addition, this kit enhanced the LE classification accuracy by 36.3% compared with the diagnostic accuracy of impression diagnosis combined with only pathological analysis. CONCLUSIONS: This skin in situ immune cell detection kit may assist doctors in achieving a higher diagnostic performance and price ratio and enhance their diagnostic efficiency.